Role of Non-Selective Beta-Adrenergic Blocker in Severe Traumatic Brain Injury
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Mortality
研究概览
简要总结
The role of nonselective beta adrenergic blocker as antistress agent in severe traumatic brain injury
详细描述
The primary injury occurs at the time of trauma. secondary injury is caused by complications of the primary insult and caused by processes such as hypoxia, cerebral edema and ischemia.
Severe traumatic brain injury is associated with increased intracranial pressure, activation of the sympathetic nervous system and catecholamine response and major morbidity and mortality .
β-blockade is just one pharmacologic strategy to reduce sympathetic hyperactivity. In the Intensive care unit patients with severe traumatic brain injury associated with restlessness and agitation are frequently sedated and intubated in order to reduce the workload of the brain. This hyperactive response is called sympathetic storming which occurs within 24 hours of brain injury or weeks later . It occurs due to acceleration in sympathetic nervous system activity in the central nervous system which results in loss of cortical control due to downregulation of autonomic balance in the brain injury .
A Non-Selective beta-adrenergic antagonist propranolol, is one of the most customarily used treatments in the case of paroxysmal sympathetic hyperactivity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 18and 65 years old
- •Patients who have Severe traumatic brain injury
- •Glascow outcome scale ≤ 8
排除标准
- •Patients have pre-existing heart disease.
- •If there are contraindications to β blocker.
- •penetrating traumatic brain injury.
- •pre-injury brain dysfunction.
- •β-blocker or α2-agonist use before trauma.
研究组 & 干预措施
Propranolol group
This group Will receive propranolol intravenously at a dose of 1 mg every 6 h for 7 days.
干预措施: propranolol (Drug)
normal saline IV group
This group Will receive 1ml of sterile 0.9% normal saline IV every 6 hours for 7 days
干预措施: normal saline IV (Drug)
结局指标
主要结局
Mortality
时间窗: 7 days
Mortality in severe traumatic brain injury with usage of β blocker
次要结局
- Glascow outcome scale extended(7 days)
研究者
Huda Talaat Ibrahim Elkallaf
Resident of Emergency Medicine and Traumatology
Tanta University
